C-Path forms landmark consortium with major drug companies

Tucson's C-Path has announced the creation of the Predictive Safety Testing Consortium, an unprecedented collaborative agreement with eight major pharmaceutical companies to improve drug safety.

This sharing of potential early indicators of clinical safety, also known as biomarkers, could help the industry move towards the use of more personalized medicine.

The agreement also positions Tucson as a place for innovation and medical product development, Raymond Woosley, C-Path's president and CEO, told the Arizona Daily Star.

"If you want to see how drug development should be in the future, that discussion and planning is taking place in Tucson," he said.

The Predictive Safety Testing Consortium brings together Bristol-Myers Squibb Co., GlaxoSmithKline, Johnson and Johnson Pharmaceutical Research and Development, Merck and Co. Inc., Novartis Pharmaceutical Corp., Pfizer Inc., Roche Palo Alto, and Schering-Plough Research Institute. Stanford Research Institute, one of C-Path's founding partners, will also participate in the consortium.

These eight companies, which could be joined by at least two more, will share the drug-testing methods they have developed to predict the safety of new treatments, cross-validating each other's methods to see if the results can be reproduced.

C-Path, a neutral evaluator in the consortium, will collect the information and summarize it in a white paper for submission to the Food and Drug Administration.

Those methods that the FDA finds to be reliable and reproducible will form the basis for agency-issued guidelines about which safety tests should be used in the drug development process.

"The Predictive Safety Testing Consortium is a prime example of a collaborative culture that must exist to modernize the development process," said Health and Human Services Secretary Mike Leavitt. "The collecting and sharing of scientific information and research across the entire healthcare community is crucial to igniting the medical innovation required to keep pace with biomedical research."

C-Path, a nonprofit organization, was formed by Woosley in 2004 to help speed up the drug development process and make drugs safer. This consortium has been one of Woosley's goals since the inception of the nonprofit.

Pharmaceutical companies have had their own drug safety tests for a long time, Woosley said. The problem is that they are not approved by the FDA.

This consortium, Woosley hopes, will change that.

"The Predictive Safety Testing Consortium is an excellent example of the value of the 'neutral ground' that C-Path creates for the industry and FDA to focus on the science that is important for drug development," Woosley said. "This is just the first of many projects that C-Path plans to support."

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For more information:

FDA Press Release

"Institute joins study on medicine," Arizona Republic, 03/18/2006

"C-Path forms drug-testing pact," Arizona Daily Star, 03/17/2006